Department of Pharmacology, School of Medical Science and Research, Sharda University, Greater Noida, Uttar Pradesh, India.
Department of Pharmacology, Maulana Azad Medical College and Associated Hospitals, New Delhi, India.
Indian J Pharmacol. 2022 Jul-Aug;54(4):258-269. doi: 10.4103/ijp.ijp_700_21.
To analyze the clinical trials that are registered on the Clinical Trial Registry of India (CTRI) portal for a year, for the treatment, prevention, and supportive therapy of coronavirus disease-19 (COVID-19).
All the trials registered on CTRI (since January 2020 till January 2021) for therapeutic, preventive, and supportive interventions for COVID-19 were searched with the keywords "Coronavirus," "COVID-19," "SARS-COV-2," and "2019-nCoV". These registered studies were analyzed as follows: Trials under different systems of Medicine-Allopathy/Homeopathy/Ayurveda/Unani/Yoga/Naturopathy. The Allopathy trials were further analyzed in detail: Intervention, design, comparator, number of subjects, duration, and approvals taken.
A total of 1597 records were found. After excluding the overlaps, behavioral and other studies conducted to understand the diagnosis, epidemiology, a total of 419 registered studies were included for further analysis. Out of these 419 studies, 166 (39.6%) were in Ayurveda, 154 (36.7%) in Allopathy, 33 (7.8%) in Homeopathy, 30 (7%) in Unani/Siddha, 18 (4.3%) in Yoga and Naturopathy and 18 (4.3%) in Nutraceuticals. A total of 264 interventions had been registered in 419 clinical trials. Sixty-seven interventions were being studied under allopathy in 154 studies. Same product was being evaluated in differently designed protocols with different endpoints. Maximum number of trials and subjects were for Hydroxychloroquine 25 (17,998), Ivermectin 11 (2820), Convalescent Plasma 11 (3982), Remdesivir 8 (3725), Tocilizumab 6 (884), and Azithromycin 6 (582).
In response to the COVID-19 pandemic, Indian researchers came forward from all the systems of medicine to evaluate interventions for prophylaxis or treatment of the disease. The involvement of AYUSH systems of medicine was specifically more in this regard. A wide variation and heterogeneity in doses and outcomes were observed in trial designs which might make it difficult to generalize the study results when they are made available. Urgent analyses of studies involving interventions on the treatment advisory of the Government may help the healthcare providers take more informed decisions for managing COVID-19 patients in India.
分析在印度临床试验注册中心（CTRI）注册的一年中，用于治疗、预防和支持冠状病毒病 19（COVID-19）的临床试验。
检索了 CTRI（自 2020 年 1 月至 2021 年 1 月）上针对 COVID-19 的治疗、预防和支持干预措施的所有试验，关键词为“冠状病毒”、“COVID-19”、“SARS-COV-2”和“2019-nCoV”。对这些已注册的研究进行了如下分析：不同医学体系（全西医/顺势疗法/阿育吠陀/尤纳尼/瑜伽/顺势疗法/自然疗法）的试验。进一步对全西医试验进行了详细分析：干预措施、设计、对照、受试者数量、持续时间和批准情况。
共发现 1597 条记录。排除重叠后，对行为和其他旨在了解诊断、流行病学的研究进行了分析，共纳入 419 项已注册研究进行进一步分析。在这 419 项研究中，166 项（39.6%）来自阿育吠陀，154 项（36.7%）来自全西医，33 项（7.8%）来自顺势疗法，30 项（7%）来自尤纳尼/悉达，18 项（4.3%）来自瑜伽和顺势疗法，18 项（4.3%）来自营养补充剂。在 419 项临床试验中，共注册了 264 项干预措施。在 154 项研究中，有 67 项干预措施正在全西医中进行研究。同一种产品在不同设计方案和不同终点下进行评估。羟氯喹的试验数量和受试者数量最多，为 25 项（17998 名），伊维菌素 11 项（2820 名），恢复期血浆 11 项（3982 名），瑞德西韦 8 项（3725 名），托珠单抗 6 项（884 名），阿奇霉素 6 项（582 名）。
为应对 COVID-19 大流行，印度研究人员来自所有医学体系，评估疾病预防或治疗的干预措施。在这方面，阿育吠陀医学体系的参与尤为突出。试验设计中的剂量和结果存在广泛的差异和异质性，这可能使研究结果在获得时难以推广。对涉及政府治疗建议的干预措施的研究进行紧急分析，可能有助于医疗保健提供者在印度管理 COVID-19 患者时做出更明智的决策。
